Excellence In Peripheral Artery Disease Thrombin Receptor Antagonist Intervention In Claudication Evaluation (XLPAD-TRACE Trial)

Who is this study for? Patients with peripheral artery disease
What treatments are being studied? Vorapaxar
Status: Unknown status
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a Phase 4, randomized clinical trial to evaluate whether addition of Vorapaxar 2.08 mg daily vs. placebo daily on background antiplatelet therapy, prescribed for 6 months to patients with established peripheral artery disease (PAD) and Intermittent Claudication (IC) treated with standard medical therapy (SMT) would lead to an improvement in the peak walking time (PWT).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: No
View:

• Treadmill PWT= 2-10 min on Gardner protocol

• Estimated survival ≥1 year in the judgment of the site investigator

• Use of at least one aspirin dose within at least 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose prior to randomization at 81 mg dose in patients on chronic (>5 days) aspirin therapy (at clinically indicated doses).

• Presence of any one of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), lipid lowering therapy, aspirin and beta-blocker drugs]

Locations
United States
Arizona
Southern Arizona VA Health Care System
Recruiting
Tucson
California
San Diego VA Medical center
Recruiting
San Diego
Colorado
VA Eastern Colorado Healthcare System
Recruiting
Denver
Georgia
Atlanta Heart Specialists
Recruiting
Atlanta
Minnesota
Minneapolis Heart Institute Foundation
Recruiting
Minneapolis
Minneapolis VA Medical center
Recruiting
Minneapolis
Nebraska
Creighton University
Recruiting
Omaha
New York
Northwell Health
Recruiting
Manhasset
Oklahoma
OKlahoma VA Medical Center
Recruiting
Oklahoma City
Oregon
VA Portland Health Care System
Recruiting
Portland
Texas
VA North Texas Health Care System
Recruiting
Dallas
Texas Tech University Health Science Center
Recruiting
Lubbock
Contact Information
Primary
Ishita Tejani, BDS, MS, MSPH
ishita.tejani@va.gov
214-857-3048
Time Frame
Start Date: July 2016
Completion Date: July 2019
Participants
Target number of participants: 200
Treatments
Placebo Comparator: SMT+APT+Placebo
Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min~Background Antiplatelet Therapy (APT) :At least one aspirin dose within 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose within 5 days prior to randomization at 81 mg dose in patients on chronic (>5 days of prior use) aspirin therapy.
Active Comparator: SMT+APT+Vorapaxar
Standard Medical Therapy (SMT): Presence of any two of the listed classes of agents [angiotensin converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB), statin therapy and beta-blocker drugs] + ability to perform at least 15 min of home walking a day, at least 3 times/week, at ≥20 steps/min~Background Antiplatelet Therapy (APT) :At least one aspirin dose within 5 days prior to randomization at 325 mg dose in aspirin naïve patients (0-5 days of prior aspirin use) or at least one aspirin dose within 5 days prior to randomization at 81 mg dose in patients on chronic (>5 days of prior use) aspirin therapy.~Vorapaxar: Vorapaxar 2.08mg/day
Sponsors
Leads: North Texas Veterans Healthcare System

This content was sourced from clinicaltrials.gov

Similar Clinical Trials